Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01317667
First received: March 9, 2011
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

This study is a Phase 1, escalating, multiple-dose, single-center study to evaluate the safety and immunogenicity of the RVEc vaccine.

The two principal hypotheses to be tested are: RVEc vaccine will display an acceptable safety profile as determined by adverse event data and RVEc vaccine will elicit ELISA IgG titers greater than or equal to 1:500 and TNA anti-ricin toxin-neutralizing antibody titers greater than or equal to 1:50 in vaccine recipients.


Condition Intervention Phase
Focus: Ricin Vaccine for Safety and Immuogenicity Outcome
Biological: RVEc
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Phase 1 Escalating, Multiple-Dose Study to Evaluate the Safety and Immunogenicity of Recombinant Ricin Toxin A-Chain 1-33/44-198 (rRTA 1-33/44-198) Vaccine (RVEc™) in Healthy Adults

Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • The nature, severity, relationship to vaccine, treatment or intervention offered if any, resolution or outcome, and frequency of adverse events (AE) for the assessment population (all subjects receiving one or more vaccinations under this protocol). [ Time Frame: Subjects will be followed for safety for 7 months after the last dose of the vaccine; SAEs for duration for study ] [ Designated as safety issue: Yes ]
    Endpoint measurements will be evaluated on a per dose basis and overall. Percentage of vaccinated subjects 1)without symptoms, 2)with any category of local reaction (grade 1-4), 3)with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4), 4)with generalized allergic reactions, 5)with each AE will be reported.


Secondary Outcome Measures:
  • Total anti-ricin IgG antibody titers as determined by the enzyme-linked immunosorbent assay (ELISA) and anti-ricin toxin-neutralizing antibody titers as determined by the colorimetric toxin neutralization assay (TNA) at all specified time points. [ Time Frame: Time points include: 7, 14, and 28 days after each vaccination, 6 months, the 9-month close-out evaluation, and 12 months ] [ Designated as safety issue: No ]
    Endpoint measurements will be evaluated for subjects in the per protocol population (subjects compliant with vaccination and titer schedules, including those subjects who received three doses of the vaccine and had at least one titer result after dose 3 and then withdrew from the study).


Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Biological: RVEc
20ug/dose x 3 doses
Other Name: 20ug dose
Experimental: Group 2 Biological: RVEc
50ug/dose x 3 doses
Other Name: 50ug dose
Experimental: Group 3 Biological: RVEc
100ug/dose x 3 doses
Other Name: 100ug dose

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Study subjects must be 18-50 years old.
  • Subjects must weigh at least 110 pounds.
  • Subjects must be in good health as judged from medical history, physical examination, EKG and chest x-ray, complete blood count (CBC) with differential, clinical chemistries, urinalysis, hepatitis serology, and HIV antibody test, and be medically cleared for participation by an investigator. If any HIV or hepatitis testing is positive, the individual will be provided with counseling and referral for health care.
  • Females of childbearing potential must have a negative pregnancy test on vaccination day before each dose and agree to not become pregnant or breastfeed for 3 months after the last dose of the vaccine and be willing to use a reliable form of contraception during the study.
  • Study subjects must read and sign an approved informed consent.
  • Study subjects must be willing to complete a subject diary card after each vaccination.
  • Study subjects must be willing to return for all follow-up visits.
  • Study subjects must agree to report any AE that may or may not be associated with administration of the investigational product through the 9-month follow-up visit. Study subjects will report all serious adverse events for the duration of the study.

Exclusion Criteria:

  • Body weight less than 110 pounds.
  • Acute or chronic medical conditions or immunodeficiency from a medical condition or medical treatment, medications, or dietary supplements that, in the investigator's opinion, would impair the subject's ability to respond to vaccination.
  • Severe hypersensitivity to any vaccine (anaphylaxis, angioedema, bronchospasm, or laryngospasm).
  • History of asthma, chronic obstructive pulmonary disease, or other current/residual disease of the lungs.
  • Clinically significant abnormal laboratory tests.
  • Current smoker.
  • Any known allergies to sodium succinate, Tween-20 (a detergent), aluminum hydroxide, or kanamycin.
  • Previously received ricin toxin vaccine or has antibodies to ricin toxin proteins.
  • Receipt of licensed vaccines within 30 days prior to the start of the study or plans to receive other vaccines during the initial 9 months of the study (the only exceptions are the inactivated influenza vaccine that can be received at least 30 days after RVEc Dose 3).
  • Receipt of investigational drug/test product within 30 days prior to entry or within the initial 9 months of the study.
  • Females: Pregnant or breastfeeding.
  • Enrolled in another greater than minimal risk study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317667

Locations
United States, Maryland
Clinical Research Department, U.S. Army Medical Research Institute of Infectious Diseases
Fort Detrick, Maryland, United States, 21702
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Ronald Reisler, MD United States Army Medical Research Institute of Infectious Diseases
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01317667     History of Changes
Other Study ID Numbers: S-10-0002, FY09-03, A-16390
Study First Received: March 9, 2011
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
Ricin
RVEc

ClinicalTrials.gov processed this record on September 16, 2014